Develop 21 CFR Part 11 Compliant FBD Software

@stolzenterprises

The professional with 16 years of experience in Industrial Automation. Development,Commissioning of PLC Control System, HMI and SCADA^^ ◾ PLC-Siemens [S7-1500F/H, S7-400, S7-400F/H/R, S7-300, S7-1200, S7-200, S5, TI PLC, LOGO!] Rockwell [(Allen Bradley)- SLC500,MicroLogix,CompactLogix.] Schneider [Zelio, M171/72] Automation Direct [DirectLogic Click PLC] Unitronic [V200-18-E3XB Controller] Delta [Delta DVP ES2] ◾HMI-Siemens ** Weintek ** Kinco ** Unitronics ** Hitachi ** Schneider ** Wecon ** DeepSeaElectronics ◾SCADA -WinCC ** In-Touch Wonderware ** Citect ** Ignition ◾ Industrial Networks-PPI-MPI ** Profibus ** AS-i ** Profinet ** Ethernet ** Modbus RTU/Modbus TCP ◾ OPC -PC Access ** OPC Scout ** OPCUA ** Metrikon ** Kepware ◾ Project Documentation-ISA88/95, GAMP, 21CFR Part11, VP, URS, FRS, DS, IQ, OQ, PQ, SOP. ◾ Programming Languages -C# ** VBA  ** VB.net ** Javascript ◾ Raspberry pi ** Raspi Camera ◾ Networking Devices - Siemens scalance, Teltonika, Waveshare Modbus Gateway, Moxa Gateway

@cesur135

Drawing from my extensive experience in industrial automation, I am confident in my ability to develop a **21 CFR Part 11 compliant software system** for your Fluid Bed Dryer (FBD) machine. Over the years, I have developed a deep understanding of FDA regulations, particularly **21 CFR Part 11 compliance**, and have successfully implemented several GxP automation projects like yours. Not only am I skilled in requirement gathering and system development, but I'm also well-versed with validation, commissioning, and final execution - essential components of this project. In addition to regulatory compliance, my expertise extends to troubleshooting and optimizing existing systems. I will leverage this capability to seamlessly integrate the new software with your existing PLC/HMI program, I/O details, process parameters, batch sequence et.al., ensuring a smooth transition while upgrading your machine's capabilities. Furthermore, my past experience in generating SOPs for system operations, user management strategies, backup management procedures etc. would be invaluable in creating the compliance-focused documentation you seek. Having worked on another regulated manufacturing industry - the wastewater and water treatment plant automation projects - I understand the importance of data integrity in GxP environments like yours. You can rely on me to design a secure database with solid data storage and retrieval processes. My experience ranges from ensuring

@hayteekeys

HI, KINDLY READ THROUGH MY PROPOSAL I will take full ownership of delivering a complete 21 CFR Part 11 / GxP-compliant software system for your Fluid Bed Dryer — from platform recommendation and development through integration, validation documentation and commissioning. MY APPROACH ✅ End-to-end CSV responsibility: URS → design → development → FAT/SAT → IQ/OQ ✅ Secure electronic records, e-signatures, audit trail and role-based access ✅ Batch management, reporting, data integrity and backup/archival strategy ✅ Full integration with existing PLC/HMI and process parameters ✅ Complete, audit-ready validation documentation package DELIVERABLES - Recommended platform, architecture and license list - Fully compliant software system integrated to the FBD - Complete validation docs (URS, FS, risk assessment, IQ/OQ, SOPs etc.) - Commissioning support and hand-over QUESTIONS 1. Existing PLC/HMI brand and communication protocols available? 2. Preferred platform family (Siemens, Rockwell, Ignition, AVEVA etc.) if any? 3. Target timeline and any site-specific validation templates? Ready to start as soon as machine details and access to existing programs are shared.

@mcollinscalz

Hello my name is Collins and I offer end-to-end expertise in GxP automation, Computer System Validation (CSV), and PLC/SCADA integration for pharmaceutical equipment. I will take total responsibility for transforming your non-compliant Fluid Bed Dryer control system into a fully validated, 21 CFR Part 11 compliant solution. Execution Strategy & Scope: Architecture & Licensing: Recommend a robust PLC/SCADA architecture (e.g., Siemens WinCC / Rockwell FactoryTalk / Ignition) with SQL database logging, local Server/IPC configuration, and exact license sizing (Runtime, Historian, User-Access). 21 CFR Part 11 Technical Controls: Implement role-based access, strict password policies, automated immutable audit trails, double-authentication electronic signatures for critical batch steps, and automated database backups. Batching & Reports: Configure secure batch creation, parameter tracking, alarm history, and tamper-proof PDF/print generation. CSV & V-Model Documentation: Author the complete GAMP 5 validation package: URS, FS, Risk Assessment (FMEA), Traceability Matrix, FAT/SAT, IQ/OQ protocols, and GxP SOPs. Qualifications: Extensive experience delivering CSV/CSA and 21 CFR Part 11 compliant automation for FBDs, RMGs, and granulators. Proven track record leading projects from initial URS through development, FAT/SAT, IQ/OQ execution. I am ready to review your existing PLC/HMI files to deliver a detailed technical proposal, architecture drawing, and itemized commercial quote.

@kobayasyk

hello, thanks for checking my proposal. I can take this from the compliance and automation side, not just programming. I’ll first review the existing FBD PLC/HMI, I/O, batch sequence and reports, then define the 21 CFR Part 11 gaps and recommend the right SCADA/database architecture, user roles, audit trail, e-signatures, batch reporting and backup strategy. After that, I can handle implementation, testing and the validation package including URS/FS, risk assessment, traceability, FAT/SAT and IQ/OQ documents. I’ll keep the solution practical for your existing machine rather than forcing a complete rebuild.

@VictoriaZ54

Hi, I can help develop and implement a 21 CFR Part 11 compliant control and data management solution for your Fluid Bed Dryer system, covering PLC/HMI/SCADA integration, secure user management, electronic records/signatures, audit trails, batch reporting, and validated data handling. I understand this requires both automation engineering and GxP/CSV compliance, not only software development. I will work on the complete lifecycle including platform architecture, database integration, validation documentation support (URS, FS, risk assessment, traceability, FAT/SAT, IQ/OQ), security configuration, backup strategy, and commissioning support. The solution will be structured for reliable pharmaceutical operation with proper data integrity and regulatory traceability. Question: What is the existing FBD control system platform (PLC, HMI/SCADA brand and versions), and do you already have the current application source files and validation documents available? Best regards

@vladislavl45

As an experienced Embedded Systems Engineer, I recognize the importance and necessity of developing a software system that follows strict regulatory compliance standards. With 8+ years of specializing in end-to-end hardware and firmware development for industrial applications, I've had numerous opportunities to navigate similar scopes of work to what your project demands. This includes development from requirement gathering through development, validation, commissioning, and final execution. I specialize in areas that are directly relevant for this project like PLCs, IoT systems, and communication protocols such as Modbus that would be essential in ensuring seamless integration between your existing FBD machine and the proposed software platform. I am well-versed in the industry practices surrounding electronic records management, data storage/retrieval as well as the integrity and authenticity of electronic signatures as expressed by CFR Part 11. In short, I bring a comprehensive understanding of the technical challenges inherent in your project. Providing you with a fully compliant, validated and reliable system is one of my main priorities. Consequently and consequently document preparation and management have been integral parts of my job.

@Amitkalunge1993

With 10 years of engineering experience—including 5 years dedicated strictly to the core pharmaceutical sector—I specialize in upgrading legacy solid dosage machinery into fully validated, 21 CFR Part 11–compliant systems under GAMP 5 guidelines. ​Addressing your proposal checklist: ​Proven Pharma Track Record: 5 years in core pharma executing end-to-end automation and CSV lifecycles (URS through IQ/OQ execution). Led 12+ pharma machine retrofits, including FBDs, RMGs, and Blenders, ensuring strict adherence to USFDA/MHRA data integrity standards. ​Recommended Software & Architecture: ​Platform: Siemens WinCC (with WinCC Audit) or Inductive Automation Ignition Edge, based on your existing PLC brand (Siemens, Rockwell, or Omron). Both offer native electronic signature frameworks, tamper-proof audit trails, and seamless recipe controls. ​Architecture: Industrial PC (IPC) running runtime SCADA networked directly to the FBD PLC via Industrial Ethernet. Secured local/server MS SQL database for encrypted batch reporting, automated scheduled backups, and strict role-based access. ​Scope of Deliverables ​Software Development: Multi-level user access (Operator, Supervisor, Admin) with password aging/lockout, automated batch start/stop and reporting, dual electronic signatures (Performed By / Verified By), and secure audit trail logging for all setpoints and events. ​Will provide Turnkey CSV Documentations.

@sandipm1307

As an Automation Engineer with an extensive background in industrial automation and system integration, I am confident that I possess the exact skill set you're seeking for your 21 CFR Part 11 compliant FBD Software project. I have a solid record of leveraging PLC programming and integrating various systems to develop high-performing solutions. Notably, I'm proficient with Python, Node-RED, Google Sheets, and cloud-based systems which can be useful for real-time monitoring, data logging, and remote control. In the context of pharmaceutical/regulated manufacturing settings, I understand the magnitude of operating within standardized protocols such as 21 CFR Part 11 and GxP automation. I am very conversant with electronic records management and electronic signature implementation—an essential aspect for developing reliable and compliant software systems. Additionally, my proficiency in industrial communication protocols such as Modbus TCP/RTU, OPC UA, Ethernet/IP, and MQTT further solidifies my expertise in this role. Combining my technical competencies with my dedication to delivering well-documented solutions, I believe that I will successfully create a compliant software system for your Fluid Bed Dryer machine ensuring smooth operation and minimal disruptions along the way.